After the outbreak of fungal meningitis was identified in September, a congressional committee was formed to investigate exactly what happened and recommend steps to prevent a similar occurrence in the future. The meningitis outbreak was due to a tainted injectable drug (methylprednisolone acetate) used to treat pain and swelling that was manufactured by the New England Compounding Center (NECC). Initial cases of meningitis were reported in July, but the scope of the outbreak was not fully identified until September.
The congressional committee questioned Food and Drug Administration (FDA) Commissioner Margaret Hamburg about the incident. Hamburg’s responses brought to light a patchwork of agencies that are responsible for overseeing different drug manufacturers. In the case of NECC, a compounding pharmacy, the state of Massachusetts had jurisdiction. As the committee continues its investigation, it is expected that new laws will be enacted to better define accountability.
According to the Associated Press, investigators discovered possible contaminants at the NECC facility, including mold and standing water where drugs were prepared. Based on these findings, it would appear that NECC was negligent in its manufacturing processes. As of November 15, more than 460 patients had been diagnosed with the disease and 32 had died, including several in North Carolina.
What is Negligence?
Negligence is a failure of an individual or entity (i.e., a business or the government) to exercise reasonable care in their actions. In the case of a drug manufacturer or compounding pharmacy, this would include preparation of medications in a sterile environment to ensure they were pure and free of contaminants. Ultimately, patients have a reasonable expectation that the drugs they receive are safe. And drug manufacturers have a duty to ensure they are.
If you believe you have been injured by a dangerous or tainted drug, you should speak with an attorney to learn your rights.